CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM

K994315 · Siemens Medical Solutions USA, Inc. · MOS · Feb 4, 2000 · Radiology

Device Facts

• Record ID: K994315
• Device Name: CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: MOS · Radiology
• Decision Date: Feb 4, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Siemens Magnetom CP Angio Array Coil is indicated for use as a diagnostic imaging device accessory to produce transverse, saggital, coronal and oblique images of vascular structures and soft tissue of the abdomen, pelvis and lower limbs. The design of this coil facilitates imaging larger peripheral vascular areas.

Device Story

CP Peripheral Angio Array Coil is a receiver-only accessory for the Magnetom Symphony MRI system. Device captures magnetic resonance signals to produce transverse, sagittal, coronal, and oblique images of vascular structures and soft tissue in the abdomen, pelvis, and lower limbs. Designed to facilitate imaging of larger peripheral vascular areas. Operated by trained clinical staff in a radiology setting. Output is viewed by physicians to assist in diagnostic decision-making regarding vascular and soft tissue pathology. Benefits include improved visualization of peripheral anatomy compared to standard coils.

Clinical Evidence

Bench testing only. Testing compared the CP Peripheral Angio Array Coil to existing Siemens coils, specifically evaluating Signal-to-Noise Ratio (SNR) and image uniformity. Results demonstrated equivalence to currently available predicate coils.

Technological Characteristics

Receiver-only MRI coil. Designed for use with the Magnetom Symphony system. Operates within the existing RF and gradient system architecture of the Magnetom Symphony. No changes to static field strength, RF power deposition, or acoustic noise levels. Performance metrics include SNR, image uniformity, geometric distortion, and spatial resolution.

Indications for Use

Indicated for patients requiring diagnostic imaging of vascular structures and soft tissue in the abdomen, pelvis, and lower limbs. Used as an accessory to the Magnetom Symphony MRI system.

Regulatory Classification

Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Magnetom Symphony system family of coils (K971684)

Submission Summary (Full Text)

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FEB 4 2000

Appendix 11: PMN Truthful and Accurate Statement

#### 510 (k) Summary

K994315

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

#### I. General Information.

#### Establishment:

- Siemens Medical Systems, Inc. • Address: 186 Wood Avenue South Iselin, N.J. 08830
2240869 Registration Number:

- Contact Person: Mr. Jamie Yieh Technical Specialist, Regulatory Submissions [phone] [phone]
Date of Summary Preparation: 12/21/99

#### Device Name:

CP Peripheral Angio Array Coil for the Magnetom Symphony • Trade Name:

- Classification Name: Magnetic Resonance Diagnostic Device, CFR § 892.1000
· Classification: Class II

· Performance Standards: None established under Section 514 of the Food, Drug, and Cosmetic Act.

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## II. Safety and Effectiveness Information Supporting Substantial Equivalence.

#### • Device Description:

The CP Peripheral Angio Array Coil is a receiver only coil for the Magnetom Symphony system.

#### • Intended Use

The Siemens Magnetom CP Angio Array Coil is indicated for use as a diagnostic imaging device accessory to produce transverse, saggital, coronal and oblique images of vascular structures and soft tissue of the abdomen, pelvis and lower limbs. The design of this coil facilitates imaging larger peripheral vascular areas.

## • Technological Characteristics

The magnet. RF system, and gradient system, of the MAGNETOM Symphony configured with the new CP Angio Array Coil is substantially equivalent to the standard MAGNETOM Symphony system with the currently marketed family of coils (which were described in K971684).

## · General Safety and Effectiveness Concerns:

Operation of the MAGNETOM Symphony system with the new CP peripheral Angio Array Coil is substantially equivalent to standard operation of the commercially available MAGNETOM Symphony system. The following safety parameter with action levels:

- Maximum Static Field Strength -
- Rate of Change in Magnetic Field -
- RF Power deposition -
- Acoustic Noise Levels -

and performance levels:

- -Specification Volume
- Signal to Noise -
- -Image Uniformity
- Geometric distortion -
- High contrast spatial resolution -
- -Slice profile, thickness and gap

specified by the FDA guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification. The new CP peripheral Angio Array Coil was tested for SNR and Image uniformity and the results presented in this submission show that they are equivalent to the currently available Siemens coils.

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# • Substantial Equivalence:

Laboratory and clinical testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 4 2000

Jamie Yieh Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

Re:

CP Peripheral Angio Array Coil/ MAGNETOM Symphony System Dated: December 21, 1999 Received: December 22, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Mr. Yieh:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

K994315

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sinceraty you

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) に 99 イヨノ5

# Device Name: CP Peripheral Angio Array Coil for the MAGNETOM SYMPHONY

Indications for Use:

The Siemens Magnetom CP Peripheral Angio Array Coil is primarily indicated for use as a diagnostic imaging device accessory to produce transverse, sagittal, coronal and oblique images of vascular structures and soft tissue of the abdomen, pelvis and lower limbs. The design of this coil facilitates imaging larger peripheral vascular areas.

(please do not write below this line- continue on another page if needed)

OR

Concurrence of CDRH, Office of Device Evaluation

Prescription Use >

Over-The-Counter Use

Verrill G. Hynson

(Division Sign-Off) Division of Reproductive, Abdominat, ENT, and Radiological Devices 510(k) Number